[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23980-23981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09693]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0487]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
involving a generic clearance for qualitative feedback on Agency
service delivery.
DATES: Submit either electronic or written comments on the collection
of information by June 30, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Generic Clearance for the Collection of Qualitative Feedback on Agency
Service Delivery (OMB Control Number 0697)--Extension
The information collection activity will garner qualitative
customer and stakeholder feedback in an efficient, timely manner, in
accordance with the Administration's commitment to improving service
delivery. By qualitative feedback we mean information that provides
useful insights on perceptions and opinions, but are not statistical
surveys that yield quantitative results that can be generalized to the
population of study. This feedback will provide insights into customer
or stakeholder perceptions; experiences and expectations; provide an
early warning of issues with service; or focus attention on areas where
communication, training, or changes in operations might improve
delivery of products or services. These collections will allow for
ongoing collaborative and actionable communications between the Agency
and its customers and stakeholders. It will also allow feedback
[[Page 23981]]
to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address the following: The
target population to which generalizations will be made, the sampling
frame, the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Focus groups.................. 725 1 725 1 hour, 45 1,269
minutes.
Customer comment cards/forms.. 1,200 1 1,200 15 minutes...... 300
Small discussion groups....... 725 1 725 1 hour, 45 1,269
minutes.
Customer satisfaction surveys. 6,450 1 6,450 20 minutes...... 2,129
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Total..................... 4,967
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09693 Filed 4-28-14; 8:45 am]
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